Clinical Trials /

Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma

NCT03223103

Description:

The purpose of this study is to use precision medicine in the form of a vaccine, a mutation-derived tumor antigen vaccine (MTA-based vaccine) in combination with standard care treatment of glioblastoma (GBM) and Tumor Treating Fields (TTFields). The study is designed to determine whether this treatment combination is well tolerated and safe.

Related Conditions:
  • Glioblastoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma
  • Official Title: Phase I Study of Tumor Treatment Fields and a Personalized Mutation-derived Tumor Vaccine in Patients With Newly Diagnosed Glioblastoma

Clinical Trial IDs

  • ORG STUDY ID: GCO 17-0566
  • SECONDARY ID: 16-089
  • NCT ID: NCT03223103

Conditions

  • Glioblastoma

Interventions

DrugSynonymsArms
Poly-ICLCHiltonol®Mutation-derived tumor vaccine
PeptidesPersonalized peptidesMutation-derived tumor vaccine

Purpose

The purpose of this study is to use precision medicine in the form of a vaccine, a mutation-derived tumor antigen vaccine (MTA-based vaccine) in combination with standard care treatment of glioblastoma (GBM) and Tumor Treating Fields (TTFields). The study is designed to determine whether this treatment combination is well tolerated and safe.

Detailed Description

      This is a single-arm, single institution phase 1a / 1b study to test the safety,
      tolerability, and immunogenicity of MTA-based personalized vaccine in patients with newly
      diagnosed GBM along with the use of continual TTFields. MTA-based personalized vaccine is
      prepared in the laboratory with several peptides based on each patient's own tumor sequence.

      The vaccine is given after the radiation and chemotherapy portion of the treatment, in the
      maintenance phase of temozolomide in conjunction with the TTFields.
    

Trial Arms

NameTypeDescriptionInterventions
Mutation-derived tumor vaccineExperimentalMTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields
  • Poly-ICLC
  • Peptides

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥ 18

          -  Confirmation of GBM (WHO grade IV).

          -  Maximal debulking surgery and undergo radiotherapy concomitant with Temozolomide
             (45-70Gy)

          -  Stable disease after treatment of radiation with chemotherapy

          -  Life expectancy > 16 weeks.

          -  Performance status of 0-2 (Eastern Cooperative Oncology Group).

          -  First vaccine treatment start date at least 4 weeks out but not more than 8 weeks from
             the last dose of concomitant Temozolomide or radiotherapy.

          -  Must have tumor tissue sufficient sequencing.

          -  Have adequate bone marrow function

          -  Require Dexamethasone ≤ 4mg daily on a stable dose

          -  Acceptable hematologic, hepatic, and renal function and these tests must be performed
             within 14 days prior to study

          -  The participant must be deemed competent to give informed consent.

          -  The participant must agree to use two effective forms of contraception beginning at
             least four (4) weeks prior to study entry.

        Exclusion Criteria:

          -  Progression of disease at time of screening.

          -  Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other
             implanted electronic devices in the brain, or documented clinically significant
             arrhythmias.

          -  Infra-tentorial tumor or multifocal disease.

          -  History of hypersensitivity reaction to Temozolomide.

          -  Receiving any other investigational agents.

          -  Prior history of unrelated neoplastic disease, and having received systemic therapy
             for the secondary malignancy within the twelve (12) month period preceding the
             screening evaluation.

          -  (HIV/AIDS), Chronic hepatitis B or hepatitis C.

          -  History of, or is reasonably suspected to meet criteria for the diagnosis of a known
             congenital or acquired disorder causing systemic immunosuppression.

          -  History of, or is reasonably suspected to meet criteria for the diagnosis of a
             systemic auto-immune/inflammatory disease or other autoimmune disorder with the
             exception of: Vitiligo

          -  Positive pregnancy test [45 CFR 46.203(b)].
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose-limiting toxicities (DLT)
Time Frame:42 weeks
Safety Issue:
Description:Feasibility administration of one vaccine; toxicity will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale

Secondary Outcome Measures

Measure:Toxicity grading using CTCAE scale
Time Frame:1 year
Safety Issue:
Description:Safety will be measured by number of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale
Measure:The percent Progression Free Survival (PFS)
Time Frame:6 months
Safety Issue:
Description:
Measure:Overall Survival (OS) Rate
Time Frame:1 year
Safety Issue:
Description:
Measure:Overall Response Rate
Time Frame:2 years
Safety Issue:
Description:Overall response as measured by RANO Response Criteria: Complete response, Partial response, Stable Disease, and Progressive Disease

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Adilia Hormigo

Trial Keywords

  • Brain cancer
  • Glioblastoma
  • Personalized vaccine
  • Poly-ICLC
  • Immunotherapy
  • Cancer
  • NovoTTF-200A
  • Optune
  • GBM
  • immunogenicity

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